Philippines FDA registration IVDR-00815

Elecsys Anti-HBc II

Philippines flagPhilippines·Roche Diagnostics GmbH - Sandhofer Strasse 116 68305 Mannheim Germany·Germany·Issued July 01, 2025 – April 02, 2030
Device information
Product Name
Elecsys Anti-HBc II
Registration Number
IVDR-00815
Manufacturer details
Country of Origin
Germany
Importer & distribution
Importer/Distributor
Roche (Philippines) Inc.
Registration dates
Issuance Date
July 01, 2025
Expiry Date
April 02, 2030
About this record

Access comprehensive regulatory information for Elecsys Anti-HBc II in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number IVDR-00815 and manufactured by Roche Diagnostics GmbH - Sandhofer Strasse 116 68305 Mannheim Germany in Germany. The device was registered on July 01, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Roche (Philippines) Inc.), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.

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